Glucocorticoid Administration After Traumatic Birth (NCT04852458) | Clinical Trial Compass
CompletedPhase 1
Glucocorticoid Administration After Traumatic Birth
United States133 participantsStarted 2021-05-21
Plain-language summary
This study has two components, an observational and a trial component. The observational part is being done to screen for postpartum posttraumatic stress disorder by collecting mental health assessments in women who are immediately postpartum for up to 6 weeks.
Additionally, the project has a small number of subjects that will participate in a clinical trial in which they would self-select to receive one dose of hydrocortisone intravenously while they are in the hospital. This pilot of up to 20 participants in the trial arm is designed to create a first indication of whether this could become an effective early intervention to prevent PTSD if given while trauma memories are first being formed.
This registration will list the observational part (number of participants =100) as well as the clinical trial (number of participants =20).
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (for observation and hydrocortisone treatment groups):
* Screening positive for PTSD Diagnostic and Statistical Manual of Mental Disorders-5 Criteria A (felt a threat to life or injury to self or neonate)
* Postpartum hemorrhage or emergency cesarean delivery
* Owner of a smart phone or email account
Exclusion Criteria (for observation and hydrocortisone treatment groups):
* Active uncontrolled psychological disturbances identified by current psychiatric admission
* Psychiatric consult during admission, or need for hospital appointed sitter during admission
* Non-English speakers requiring a translator
* Current corticosteroid use or corticosteroid use during the study period (including betamethasone for promoting fetal lung maturity)
* Cognitive impairment identified by medical chart review or patients requiring a legal guardian for medical decision making
Exclusion Criteria: (additional criteria for participants that will receive hydrocortisone)
* Self-reported hypersensitivity to hydrocortisone
* Inability to consent patient and administer study drug within 12 hours of a traumatic event
* Weight \< 45 kilograms (kg) or \>120kg
* Subjects with systemic active infections (e.g. viral, bacterial, fungal, protozoan, or helminthic)
* Subjects with uncontrolled hypertension, renal insufficiency, or decompensated congestive heart failure
* Subjects with inflammatory bowel disease
* Subjects with active or latent peptic ulcers
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.